Apparatuses, systems, and methods for managing liquid flow associated with a tissue site using the presence of reduced pressure

ABSTRACT

The illustrative embodiments described herein are directed to apparatuses, systems, and methods for managing liquid flow associated with a tissue site that involves using reduced pressure to control fluid flow. In one instance, an apparatus includes a first valve and a second valve in fluid communication with a reduced-pressure source. The valves are movable between an open position and a closed position and are operable to change flow status (open to closed or vice versa) based on a presence of reduced pressure. At least one of the first valve or the second valve is in the closed position to obstruct a flow of a liquid while the other is in the open position. The apparatus also includes a reservoir fluidly coupled to the first valve and the second valve. Other systems, methods, and apparatuses are presented.

RELATED APPLICATION

This application is a division of U.S. patent application Ser. No.13/931,089, filed Jun. 28, 2013, which is a division of U.S. patentapplication Ser. No. 12/640,511, filed Dec. 17, 2009, which issued asU.S. Pat. No. 8,491,540 on Jul. 23, 2013, which claims the benefit,under 35 U.S.C. §119(e), of the filing of U.S. Provisional PatentApplication Ser. No. 61/141,609 entitled “Apparatuses, Systems, andMethods for Managing Liquid flow Associated with a Tissue Site Based onthe Presence of Reduced Pressure,” filed Dec. 30, 2008, each of whichare incorporated herein by reference for all purposes.

BACKGROUND

Clinical studies and practice have shown that providing a reducedpressure in proximity to a tissue site augments and accelerates thegrowth of new tissue at the tissue site. The applications of thisphenomenon are numerous, but application of reduced pressure has beenparticularly successful in treating wounds. This treatment (frequentlyreferred to in the medical community as “negative pressure woundtherapy,” “reduced pressure therapy,” or “vacuum therapy”) provides anumber of benefits, including faster healing, and increased formulationof granulation tissue.

SUMMARY

To alleviate existing problems with medical treatment systems, theillustrative embodiments described herein are directed to apparatuses,systems, and methods for managing liquid flow associated with a tissuesite. According to an illustrative, non-limiting embodiment, a systemfor managing liquid flow associated with a tissue site includes a liquidsource operable to supply liquid, a reduced-pressure source operable tosupply reduced pressure, and a first valve in fluid communication withthe reduced-pressure source. The first valve is movable between an openposition and a closed position and is operable to be activated based ona presence of reduced pressure. The system further includes a secondvalve in fluid communication with the reduced-pressure source. Thesecond valve is also movable between an open position and a closedposition and is operable to be activated based on the presence ofreduced pressure. At least one of the first valve and the second valveis in the closed position to obstruct a flow of a liquid when underreduced pressure. The system further includes a reservoir fluidlycoupled to the first valve and the second valve. The reservoir isoperable to contain liquid from the liquid source. The system furtherincludes a first delivery conduit that is in fluid communication withthe reservoir and is operable to deliver the liquid from the liquidsource. The system also includes a second delivery conduit that is influid communication with the reservoir and is operable to deliver theliquid from the reservoir to the tissue site.

According to another illustrative, non-limiting embodiment, an apparatusfor managing liquid flow associated with a tissue site includes a firstvalve in fluid communication with a reduced-pressure source. The firstvalve is movable between an open position and a closed position and isoperable to be activated based on a presence of reduced pressure. Theapparatus further includes a second valve in fluid communication withthe reduced-pressure source. The second valve is movable between an openposition and a closed position and is operable to be activated based onthe presence of reduced pressure. At least one of the first valve andthe second valve is in the closed position to obstruct a flow of liquidwhen experiencing reduced pressure. The apparatus also includes areservoir fluidly coupled to the first valve and the second valve. Thereservoir is operable to receive liquid from a liquid source when thefirst valve is in the open position.

According to another illustrative, non-limiting embodiment, a method formanaging liquid flow associated with a tissue site includes providing avalve arrangement having a first valve, a second valve, and a reservoir,and receiving reduced pressure at the first valve and the second valve.The first valve and second valve each have an open position and a closedposition. The method further includes changing a flow status (open toclosed or vice versa) of the first valve in response to receivingreduced pressure at the first valve, receiving a liquid at the reservoirwhen the first valve is open, changing a flow status of the second valvein response to receiving reduced pressure at the second valve, andobstructing a flow of liquid from the reservoir when the second valve isclosed.

According to another illustrative, non-limiting embodiment, a method formanaging liquid flow associated with a tissue site includes providing avalve arrangement with a first valve, a second valve, and a reservoir.The method also includes fluidly coupling the first valve to a liquidsource, fluidly coupling the second valve to the tissue site, changing aposition of the first valve to one of an open position and a closedposition based on a presence of reduced pressure at the first valve, andchanging a position of the second valve to the other of the openposition and the closed position based on a presence of reduced pressureat the second valve.

According to another illustrative, non-limiting embodiment, a method ofmanufacturing an apparatus for managing liquid flow associated with atissue site includes providing a first valve moveable between an openposition and a closed position and operable to change flow status basedon a presence of reduced pressure, providing a second valve moveablebetween an open position and a closed position and operable to changeflow status based on the presence of reduced pressure, and providing areservoir operable to contain a liquid. The method further includescoupling the reservoir to the first valve and the second valve such thatthe reservoir is disposed between the first valve and the second valve.

According to another illustrative, non-limiting embodiment, a method ofmanufacturing an apparatus for managing liquid flow associated with atissue site includes providing a first sheet, providing a second sheet,providing a foam member, and coupling the first sheet to the secondsheet to form a reduced-pressure conduit, a reservoir, a first valve,and a second valve. The foam member is enclosed between the first sheetand the second sheet.

Other features and advantages of the illustrative, non-limitingembodiments will become apparent with reference to the drawings anddetailed description that follow.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete understanding may be obtained by reference to thefollowing Detailed Description when taken in conjunction with theaccompanying Drawings, wherein like numerals indicate like elementsthroughout, and wherein:

FIG. 1 is a schematic diagram of a treatment system for managing liquidflow associated with a tissue site in accordance with an illustrativeembodiment;

FIG. 2 is a schematic, perspective view of an apparatus for managingliquid flow associated with a tissue site in accordance with anillustrative embodiment;

FIG. 3 is a schematic, exploded perspective view of an apparatus formanaging liquid flow associated with a tissue site in accordance with anillustrative embodiment;

FIG. 4 is a schematic cross-sectional view of the apparatus of FIG. 2taken along line 4-4 when at least a portion of the apparatus is exposedto reduced pressure;

FIG. 5 is a schematic cross-sectional view of the apparatus of FIG. 2taken along line 4-4 when reduced pressure is absent from the apparatus;

FIG. 6A is a schematic cross-sectional view of a valve in an openposition in accordance with an illustrative embodiment;

FIG. 6B is a schematic cross-sectional view of a valve in a closedposition in accordance with an illustrative embodiment; and

FIG. 7 is a schematic graph illustrating the level of reduced pressureover time in an apparatus for managing liquid flow associated with atissue site in accordance with an illustrative embodiment.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

In the following detailed description of the illustrative embodiments,reference is made to the accompanying drawings that form a part hereof.These embodiments are described in sufficient detail to enable thoseskilled in the art to practice the invention, and it is understood thatother embodiments may be utilized and that logical structural,mechanical, electrical, and chemical changes may be made withoutdeparting from the spirit or scope of the invention. To avoid detail notnecessary to enable those skilled in the art to practice the embodimentsdescribed herein, the description may omit certain information known tothose skilled in the art. The following detailed description is,therefore, not to be taken in a limiting sense, and the scope of theillustrative embodiments are defined only by the appended claims.

Referring primarily to FIG. 1, a system 100 for managing liquid flowassociated with a tissue site 103 is shown according to an illustrativeembodiment. An apparatus 106, or valve arrangement, which is included inthe system 100, manages the flow of liquid from a liquid source 109 tothe tissue site 103. The apparatus 106 may control the amount of liquidthat flows to the tissue site 103, including whether the liquid flows tothe tissue site 103 at all. The apparatus 106 uses reduced pressure froma reduced-pressure source 115 to help manage liquid flow from the liquidsource 109 to the tissue site 103.

As used herein, “reduced pressure” generally refers to a pressure lessthan the ambient pressure at a tissue site that is being subjected totreatment. In most cases, this reduced pressure will be less than theatmospheric pressure at which the patient is located. Alternatively, thereduced pressure may be less than a hydrostatic pressure at the tissuesite. Unless otherwise indicated, values of pressure stated herein aregauge pressures. The reduced pressure delivered may be constant orvaried (patterned or random) and may be delivered continuously orintermittently. Although the terms “vacuum” and “negative pressure” maybe used to describe the pressure applied to the tissue site, the actualpressure applied to the tissue site may be more than the pressurenormally associated with a complete vacuum. Consistent with the useherein, an increase in reduced pressure or vacuum pressure typicallyrefers to a relative reduction in absolute pressure. Unless otherwiseindicated, as used herein, “or” does not require mutual exclusivity.

The reduced-pressure source 115 supplies reduced pressure to theapparatus 106 via the tissue site 103. The reduced pressure may besupplied from the reduced-pressure source 115 to the tissue site 103through a conduit 116. Residual reduced pressure may continue to besupplied by at least a portion 112 of the tissue site 103 to theapparatus 106 even when the reduced-pressure source 115 is turned off—atleast until the reduced pressure in the tissue site is disseminated. Thereduced-pressure source 115 may be any device or system that generatesor provides a reduced pressure, including, but not limited to, manuallyoperated or powered pumps or wall suction. As non-limiting examples, thereduced-pressure source 115 may include devices that are manuallyactuated, battery operated, or any form of pneumatic pump. In oneexample, the pump uses low amounts of power and is capable of operatingfor an extended period of time on a single charge of the battery. Asanother non-limiting example, the reduced-pressure source 115 may bewall suction. As shown by the non-limiting examples, the possibilitiesfor the reduced-pressure source 115 are numerous.

The liquid source 109 supplies liquid to the tissue site 103 via theapparatus 106. The liquid source 109 may be any container, bag, or otherdevice capable of holding a liquid. The liquid supplied by the liquidsource 109 may be any liquid, including liquids that contain solidparticles. In one example, the liquid supplied by the liquid source 109may facilitate the healing or growth of the tissue site 103. The liquidsupplied by the liquid source 109 may contain growth factors, healingfactors, antibiotics, medicines, etc.

The tissue site 103 may be the bodily tissue of any human, animal, orother organism, including adipose tissue, muscle tissue, dermal tissue,vascular tissue, connective tissue, cartilage, tendons, ligaments, bone,or any other tissue. While the tissue site 103 may include a wound(including an open wound or an incision), diseased tissue, or defectivetissue, the tissue site 103 may also be healthy tissue that is notwounded, diseased, or defective. The application of reduced pressure tothe tissue site 103 may be used to promote the drainage of exudate andother liquids from the tissue site 103, as well as stimulate the growthof additional tissue. In the case in which the tissue site 103 is awound site, the growth of granulation tissue and removal of exudates andbacteria promotes healing of the wound. The application of reducedpressure to non-wounded or non-defective tissue, including healthytissue, may be used to promote the growth of tissue that may beharvested and transplanted to another tissue location. The delivery ofliquid from the liquid source 109 to the tissue site 103 via theapparatus 106 may be used in conjunction with the application of reducedpressure to the tissue site 103 to facilitate the healing, growth, orother treatment of the tissue site 103.

The apparatus 106 for managing liquid flow to the tissue site 103includes a first valve 118 in fluid communication with thereduced-pressure source 115. In one example, fluid communication betweenthe first valve 118 and the reduced-pressure source 115 may be provided,at least in part, by an intermediate reduced-pressure conduit, orreduced-pressure conduit 121. The first valve 118 is movable between anopen position and a closed position. In an open position, the firstvalve 118 may be partially or fully open, and liquid from the liquidsource 109 is allowed to pass through the first valve 118 and into areservoir 124 that is operable to contain the liquid. In a closedposition, the first valve 118 may be partially or fully closed, and thefirst valve 118 obstructs or prevents the flow of liquid from the liquidsource 109 into the reservoir 124.

The first valve 118 is activated, or changes flow status, i.e., movesfrom the open position to the closed position or vice versa, based on apresence or absence of reduced pressure at the first valve 118. Thereduced pressure may be transferred to the first valve 118 from thereduced-pressure source 115 to the first valve 118 at least in part bythe reduced-pressure conduit 121. In one example, the first valve 118moves from a closed position to an open position in the presence ofreduced pressure at the first valve 118, and the first valve 118 movesfrom an open position to a closed position in an absence of reducedpressure at the first valve 118. As used herein, an “absence” of reducedpressure may include a partial or total absence of reduced pressure.

The apparatus 106 also includes a second valve 127 in fluidcommunication with the reduced-pressure source 115. In one example,fluid communication between the second valve 127 and thereduced-pressure source 115 may be at least partially provided by thereduced-pressure conduit 121. In the example in which thereduced-pressure conduit 121 provides fluid communication between thesecond valve 127 and the reduced-pressure source 115, thereduced-pressure conduit 121 may be an air-permeable material, a portionof which extends into a second delivery conduit 131. The second valve127 is activated, or changes flow status, i.e., moves from an openposition to a closed position or vice versa, based on the presence orabsence of reduced pressure. In an open position, the second valve 127may be partially or fully open, and liquid from the reservoir 124 isallowed to pass through the second valve 127, into the second deliveryconduit 131, and to the tissue site 103. In the closed position, thesecond valve 127 may be partially or fully closed, and the second valve127 obstructs or prevents the flow of liquid to the into the seconddelivery conduit 131 and thus to the tissue site 103.

In one example, the second valve 127 moves between the open position orthe closed position based on a presence of reduced pressure at thesecond valve 127. In this example, the reduced pressure may betransferred to the second valve 127 from the reduced-pressure source115, at least in part, by the reduced-pressure conduit 121 and thesecond delivery conduit 131. In one example, the second valve 127 movesfrom an open position to a closed position in the presence of reducedpressure at the second valve 127, and the second valve 127 moves from aclosed position to an open position in an absence of reduced pressure atthe second valve 127.

Numerous valve types may be used for the first valve 118 and the secondvalve 127. In one embodiment, the first valve 118 and the second valve127 are pilot-actuated valves. In one example of this embodiment, thefirst valve 118 and the second valve 127 may include a master and slavecylinder, and may be made from machined brass. In another embodiment,the first valve 118 and the second valve 127 may be diaphragm valves.

In one embodiment, the reservoir 124 is operable to contain a liquid andtransport the liquid from the first valve 118 to the second valve 127.The reservoir 124 may be disposed between the first valve 118 and thesecond valve 127. In one non-limiting example, a first end 125 of thereservoir 124 is coupled to the first valve 118, and a second end 126,which is opposite the first end 125, of the reservoir 124 is coupled tothe second valve 127. As used herein, the term “coupled” includescoupling via a separate object, and also includes direct coupling. Inthe case of direct coupling, the two coupled objects touch each other insome way. The term “coupled” also encompasses two or more componentsthat are continuous with one another by virtue of each of the componentsbeing formed from the same piece of material. Also, the term “coupled”includes chemical coupling, such as via a chemical bond. The term“coupled” may also include mechanical, thermal, or electrical coupling.The term “coupled” may also include fluidly coupled, in which case afirst object that is coupled to a second object is in fluidcommunication with that second object.

As shown in the illustrative embodiments disclosed herein, thevolumetric capacity of the reservoir 124 may be varied. For example, thesize of the reservoir 124 may be increased or decreased to vary thevolumetric capacity of the reservoir 124. In one non-limiting example,the reservoir 124 may have a volumetric capacity that corresponds to apredetermined medicinal dosage such that the predetermine dosage ofmedicinal liquid is delivered to the tissue site 103 when the secondvalve 127 moves to an open position.

In one illustrative embodiment, the reservoir 124 may be flexible, inwhich case the volume of the reservoir 124 may vary depending on theamount of liquid in the reservoir 124. The flexibility of the reservoir124 may facilitate the movement of liquid out of the reservoir 124. Inanother illustrative embodiment, the reservoir 124 may be a rigidcontainer. The reservoir 124 may also include a vent line (not shown)that permits the entry of a gas, such as air, into the reservoir 124.The vent line may facilitate the movement of liquid out of the reservoir124 and toward the tissue site 103. The vent line may be associated withthe liquid source 109 or a first delivery conduit 134. Additionalillustrative, non-limiting embodiments suitable for use as the reservoir124 are provided below in FIGS. 2-5.

In one illustrative, non-limiting embodiment, the valves 118, 127 areconfigured to operate according to the following TABLE 1.

TABLE 1 Pressure Status At Tissue Site First Valve 118 Second Valve 127Reduced Pressure Present Open Closed Reduced Pressure Not Present ClosedOpen

The position of the valves could be readily changed to be the oppositeof what is shown in TABLE 1 for the different pressure statuses as shownin TABLE 2.

TABLE 2 Pressure Status At Tissue Site First Valve 118 Second Valve 127Reduced Pressure Present Closed Open Reduced Pressure Not Present OpenClosed

At least one of the first valve 118 and the second valve 127 is in aclosed position to obstruct or prevent the flow of the liquid. In theillustrative, non-limiting example represented in TABLE 1, the firstvalve 118 has one of an open position or a closed position and thesecond valve 127 has the other of the open position or the closedposition such that the first valve 118 and the second valve 127 eachhave different positions. When reduced pressure is present at the tissuesite 103, the reduced pressure may be transferred to the first valve 118and the second valve 127 by conduits 131 and 121 to cause the firstvalve 118 to have an open position and the second valve 127 to have aclosed position. When the first valve 118 is in an open position and thesecond valve 127 is in a closed position, liquid is allowed to move fromthe liquid source 109 to the reservoir 124, but the second valve 127obstructs or prevents the liquid from moving into conduits 121 and 131and thus to the tissue site 103. The reservoir 124 may then be allowedto fill to a predetermined volume, such as a predetermined medicinaldosage.

The absence of reduced pressure at the tissue site 103 may cause thefirst valve 118 to have a closed position and the second valve 127 tohave an open position. When the first valve 118 has a closed positionand the second valve 127 has an open position, liquid is allowed to movefrom the reservoir 124 to the tissue site 103, but the first valve 118obstructs or prevents the liquid from moving to the reservoir 124 fromthe liquid source 109. Thus, the predetermined volume of liquid in thereservoir 124 is delivered to the tissue site 103 while the first valve118 helps to prevent additional liquid from being added to thepredetermined volume of liquid delivered from the reservoir 124.

In one embodiment, the system 100 includes the first delivery conduit134 that is in fluid communication with the first valve 118, and whenthe first valve 118 is open, with reservoir 124. The first deliveryconduit 134 is operable to deliver the liquid from the liquid source 109to the apparatus 106. The first delivery conduit 134 may deliver liquidfrom the liquid source 109 to the reservoir 124 when the first valve 118is in an open position.

In one embodiment, the system 100 includes the second delivery conduit131 that is in fluid communication with the reservoir 124 when thesecond valve 127 is in the open position. The second delivery conduit131 is operable to deliver liquid from the apparatus 106 to the tissuesite 103. For example, liquid may be delivered from the reservoir 124 tothe tissue site 103 via the second delivery conduit 131. In thisexample, the second delivery conduit 131 may deliver liquid from thereservoir 124 to the tissue site 103 when the second valve 127 is in theopen position.

In one illustrative embodiment, the reduced-pressure conduit 121 fluidlycouples the first valve 118 and the second delivery conduit 131. Inaddition, the reduced-pressure conduit 121 may fluidly couple the firstvalve 118 and the second valve 127. In the illustrative embodiment ofFIG. 1, reduced pressure is delivered through the second deliveryconduit 131 to the reduced-pressure conduit 121, which delivers thereduced pressure to the first valve 118 and the second valve 127.

In one non-limiting example, reduced pressure from the tissue site 103is transferred to the reduced-pressure conduit 121 by the seconddelivery conduit 131. The reduced-pressure conduit 121 has a firstportion 140 and a second portion 137. The first portion 140 of thereduced-pressure conduit 121 transfers reduced pressure from the seconddelivery conduit 131 to the first valve 118. The second portion 137 ofthe reduced-pressure conduit 121 transfers reduced pressure from thesecond delivery conduit 131 to the second valve 127.

In another non-limiting example, the second delivery conduit 131 maydirectly deliver reduced pressure from the tissue site 103 to the secondvalve 127 without the intervening reduced-pressure conduit 121 (oralternatively, the second portion 137 may comprise a portion of thesecond delivery conduit 131). In this non-limiting example, thereduced-pressure conduit 121 may be in fluid communication with thefirst valve 118, and may be operable to transmit reduced pressuredirectly from the tissue site 103 to the first valve 118. Also, in thisnon-limiting example, the reduced-pressure conduit 121 may be fluidlycoupled to the second delivery conduit 131 or the tissue site 103.

The system 100 may also include a manifold 143 that may be placedadjacent or in contact with the tissue site 103. The manifold 143 maydistribute the liquid received from the apparatus 106 to the tissue site103. The manifold 143 may be a biocompatible, porous material that iscapable of being placed in contact with the tissue site 103 anddistributing reduced pressure or liquid to the tissue site 103. Themanifold 143 may be made from foam, gauze, felted mat, or other suitablematerial or structure that distributes reduced pressure. The manifold143 may include a plurality of flow channels or pathways to facilitatedistribution of reduced pressure or liquid to or from tissue site 101.

The manifold 143 may further serve as a scaffold for new cell-growth, ora scaffold material may be used in conjunction with the manifold 143 topromote cell-growth. A scaffold is a substance or structure used toenhance or promote the growth of cells or formation of tissue, such as athree-dimensional porous structure that provides a template for cellgrowth. Illustrative examples of scaffold materials include calciumphosphate, collagen, PLA/PGA, coral hydroxy apatites, carbonates, orprocessed allograft materials. In one example, the scaffold material hasa high void-fraction (i.e. a high content of air). In anotherembodiment, the system 100 does not include the manifold 143.

By using reduced pressure from the reduced-pressure source 115, thesystem 100 is able to effectively manage the flow of liquid from theliquid source 109 to the tissue site 103. Measured dosages of liquid,such as a medicinal liquid, may be released from the reservoir 124 tothe tissue site 103 at predetermined time intervals. For example,reduced pressure from the reduced-pressure source 115 may be applied tothe tissue site 103 in a cyclic manner to determine when liquid isreleased from the reservoir 124 to the tissue site 103. In this example,when the reduced-pressure source 115 applies reduced pressure to thetissue site 103, the reduced pressure is transferred to the first valve118 and the second valve 127 to cause the first valve 118 to have anopen position and the second valve 127 to have a closed position. Thus,liquid is allowed to flow from the liquid source 109 to the reservoir124, but is obstructed from flowing from the reservoir 124 to the tissuesite 103. When the reduced-pressure source 115 ceases to apply reducedpressure to the tissue site 103, thereby causing an absence of reducedpressure at the tissue site 103, the first valve 118 may transition to aclosed position and the second valve 127 transition to an open position.Thus, a measured dosage of liquid in the reservoir 124 is allowed toflow to the tissue site 103, and the first valve 118 obstructs liquidfrom flowing into the reservoir 124 from the liquid source 109. In thismanner, the reduced pressure applied to the tissue site 103 by thereduced-pressure source 115 may be cycled to manage the application ofliquid to the tissue site 103.

In one embodiment, a method for managing liquid flow associated with thetissue site 103 may include receiving reduced pressure at the firstvalve 118 and the second valve 127. The reduced pressure may be receivedby the first valve 118 and the second valve 127 via the reduced-pressureconduit 121 or the second delivery conduit 131. The method may alsoinclude opening the first valve 118 in response to receiving reducedpressure at the first valve 118. The method may also include receiving aliquid at the reservoir 124 in response to opening the first valve 118.The method may also include closing the second valve 127 in response toreceiving reduced pressure at the second valve 127. The method may alsoinclude obstructing a flow of liquid from the reservoir 124 in responseto closing the second valve 127. “Obstructing” includes partially orfully obstructing.

In one embodiment, the method may also include closing the first valve118 in response to an absence of reduced pressure at the first valve118. The reduced-pressure source 115 may cease to supply reducedpressure to the tissue site 103 and thus cause an absence of reducedpressure at the first valve 118. The method may also include obstructingthe flow of liquid from the liquid source 109 to the reservoir 124 inresponse to closing the first valve 118. The second valve 127 may openin response to the absence of reduced pressure at the second valve 127.The tissue site 103 may then receive liquid from the reservoir 124 inresponse to opening the second valve 127.

In another embodiment, a method for managing liquid flow associated withthe tissue site 103 may include changing a position of the first valve118 to one of an open position or a closed position based on thepresence of reduced pressure at the first valve 118. The method alsoincludes changing a position of the second valve 127 to the other of theopen position or the closed position. The method may also includeobstructing a flow of liquid using the valve having the closed position,which, in this embodiment, may be either the first valve 118 or thesecond valve 127.

In one example, changing the position of the first valve 118 to one ofthe open position or the closed position based on the presence ofreduced pressure at the first valve 118 includes changing the positionof the first valve 118 from the closed position to the open position inthe presence of reduced pressure. In another example, changing theposition of the first valve 118 to one of the open position or theclosed position based on the presence of reduced pressure at the firstvalve 118 includes changing the position of the first valve 118 from theopen position to the closed position in an absence of reduced pressure.In another example, the first valve 118 is in the closed position, andobstructing the flow of liquid using the valve having the closedposition includes obstructing the liquid from being received by thereservoir 124 using the first valve 118. In another example, the methodmay include receiving liquid at the reservoir 124 when the first valve118 is in the open position.

In one example, changing the position of the second valve 127 to theother of the open position or the closed position includes changing theposition of the second valve 127 from the open position to the closedposition in the presence of reduced pressure. In another example, thesecond valve 127 is in the closed position, and obstructing the flow ofliquid using the valve having the closed position includes obstructingthe liquid from leaving the reservoir 124 using the second valve 127. Inanother example, changing the position of the second valve 127 to theother of the open position or the closed position includes changing theposition of the second valve 127 from the closed position to the openposition in an absence of reduced pressure. In another example, themethod may include receiving liquid at the tissue site 103 when thesecond valve 127 is in the open position.

In one embodiment, a method of manufacturing an apparatus for managingliquid flow associated with the tissue site 103 includes providing thefirst valve 118, which is capable of having an open position and aclosed position based on a presence of reduced pressure. The method alsoincludes providing the second valve 127, which is capable of having anopen position or a closed position based on the presence of reducedpressure. The method may also include providing the reservoir 124, whichis operable to contain a liquid, and fluidly coupling the reservoir 124to the first valve 118 and the second valve 127. The reservoir 124 maybe disposed between the first valve 118 and the second valve 127.

In one example, the method of manufacturing also includes providing thereduced-pressure conduit 121, and coupling the reduced-pressure conduit121 to at least one of the first valve 118 and the second valve 127. Inthis example, the reduced-pressure conduit 121 is operable to transferreduced pressure to at least one of the first valve 118 and the secondvalve 127.

Referring now primarily to FIGS. 2-5, an apparatus 206, or valvearrangement, is shown according to an illustrative embodiment. Theapparatus 206 may be used as the apparatus 106 in the system 100 ofFIG. 1. The apparatus 206 comprises a plurality of sheets, including afirst sheet 246, a second sheet 249, and a third sheet 252, as well as afoam member 255. In one embodiment, the first sheet 246, the secondsheet 249, the third sheet 252, and the foam member 255 may be combined(by coupling a portion, enclosing, or other techniques) with one anotherto form the various components of the apparatus 206, including the firstvalve 218, the second valve 227, the reservoir 224, and thereduced-pressure conduit 221. The first valve 218, the second valve 227,the reservoir 224, and the reduced-pressure conduit 221 are functionallyanalogous to the first valve 118, the second valve 127, the reservoir124, and the reduced-pressure conduit 121 in FIG. 1, respectively.

The first sheet 246, the second sheet 249, and the third sheet 252 maybe composed of any liquid impermeable material. Non-limiting examples ofthe material from which the first sheet 246, the second sheet 249, andthe third sheet 252 may be formed include polyvinyl chloride (PVC),polyurethane (PU), polyolefins, polyethylene (PE), polypropylene (PP),etc. In one example, the first sheet 246, the second sheet 249, and thethird sheet 252 may formed from a flexible or rigid material. Althougheach of the first sheet 246, the second sheet 249, and the third sheet252 may be composed of the same material, each of the first sheet 246,the second sheet 249, and the third sheet 252 may also be composed ofdifferent materials. For example, the third sheet 252 may be composed ofa different material than the first sheet 246 and the second sheet 249.In one non-limiting example, the first sheet 246 and the second sheet249 are approximately the same size and shape. Also, the third sheet 252may be smaller than the first sheet 246 or the second sheet 249.

The first sheet 246, the second sheet 249, the third sheet 252, and thefoam member 255 may be coupled to one another in a wide variety of waysto form the various components of the apparatus 206. In one embodiment,the first sheet 246 may be coupled to at least one of the second sheet249 and the third sheet 252 along lines 258 to form the first valve 218,the second valve 227, the reservoir 224, and the reduced-pressureconduit 221. In addition to the pattern shown in FIG. 3, the lines 258may form any pattern that provides desirable characteristics for theapparatus 206, including the various components thereof. In addition,the first sheet 246 may be coupled to at least one of the second sheet249 and the third sheet 252 at the lines 258 in any manner, includingwelding (e.g., ultrasonic or RF), bonding, adhesives (e.g., siliconeadhesive), cements, etc.

In one example, the first sheet 246 may be coupled to at least one ofthe second sheet 249 and the third sheet 252 to form the reservoir 224and the reduced-pressure conduit 221. In this example, the first sheet246 may be coupled to the second sheet 249 and the third sheet 252 alonga portion 261 of the lines 258 to form the reservoir 224. Thus, thereservoir 224 may be at least partially formed by abutting portions ofthe first sheet 246 and the second sheet 249 and abutting portions ofthe first sheet 246 and the third sheet 252. “Abutting” may mean next toeach other or near and yet spaced. In addition, the first sheet 246 maybe coupled to the second sheet 249 and the third sheet 252 along aportion 264 of the lines 258 to form the reduced-pressure conduit 221.Thus, the reduced-pressure conduit 221 may be at least partially formedby abutting portions of the first sheet 246 and the second sheet 249 andabutting portions of the first sheet 246 and the third sheet 252.

The third sheet 252 may also be coupled to the second sheet 249 alonglines 271 to form an inlet conduit 273. Thus, the inlet conduit 273 maybe at least partially formed by abutting portions of the third sheet 252and the second sheet 249. The inlet conduit 273 may transfer the liquid250 to the reservoir 224. The inlet conduit 273 may also include anaperture or hole 275, and the liquid 250 may be transferred from theinlet conduit 273 to the reservoir 224 via the hole 275. The apparatus206 also includes a first delivery conduit 234, which delivers theliquid 250 from a liquid source to the inlet conduit 273. The firstdelivery conduit 234 is insertable into the inlet conduit 273, and maybe removably coupled to the inlet conduit 273 by any technique,including interference fit.

The apparatus 206 also includes the foam member 255, which may bedisposed between the first sheet 246 and the second sheet 249 and atleast partially enclosed therebetween. In addition or alternatively, aportion 267 of the foam member 255 may also be disposed between thefirst sheet 246 and the third sheet 252. The foam member 255 is operableto transfer reduced pressure, which may be from a reduced-pressuresource, and the liquid 250, which may be from a liquid source. A portion269 of the foam member 255 may be included between the portions of thefirst sheet 246 and the second sheet 249 that form the reduced-pressureconduit 221, as well as between the portions of the first sheet 246 andthe third sheet 252 that form the reduced-pressure conduit 221. Theportion 269 of the foam member 255 may thus transfer reduced pressurethrough the reduced-pressure conduit 221. In an alternative embodiment,a portion of the foam member 255 may also be used to help form thereservoir 224.

Although in the examples of FIGS. 2-5, the foam member 255 is composedof foam, the foam member 255 may be composed of any material that iscapable of transferring reduced pressure or the liquid 250. The foammember 255 may be any manifold material. The foam member 255 may also becomposed of compressible materials.

With reference primarily to FIGS. 3-5, in one embodiment, a first end277 of the foam member 255 forms at least a portion of the first valve218. The first end 277 of the foam member 255 may be an enlarged endportion, and may have any shape, including a rectangular, circular,diamond, elliptical, or polygonal shape. In one example, the first end277 compresses in the presence of reduced pressure to a compressed state279, as shown in FIG. 4. The first end 277 may expand back to anoriginal size in an absence of reduced pressure to form an expandedstate 281, as shown in FIG. 5. When the first end 277 is in thecompressed state 279, the first valve 218 is in an open position. Whenthe first end 277 is in the expanded state 281, the first valve 218 isin a closed position. Thus, when the reduced-pressure conduit 221transfers reduced pressure to the first end 277, which forms part of thefirst valve 218, the first end 277 compresses to create a space 283through which the liquid 250 may flow. In particular, the liquid 250 mayflow from the first delivery conduit 234 and into the reservoir 224 viathe hole 275, as indicated by arrows 284. Conversely, when reducedpressure is absent at the first end 277, the first end 277 is in theexpanded state 281 to reduce or eliminate the space 283, and the liquid250 is obstructed from flowing from the first delivery conduit 234 intothe reservoir 224.

The apparatus 206 also includes the second valve 227, which may be atleast partially formed by a first wall 285 and the second wall 287. Thefirst wall 285 may be a portion of the first sheet 246, and the secondwall 287 may be a portion of the second sheet 249. In one example, thefirst wall 285 and the second wall 287 are drawn nearer to one anotherin the presence of reduced pressure to form a closed position, as shownin FIG. 4. In this example, the first wall 285 and the second wall 287may firmly abut one another to form the closed position. The first wall285 and the second wall 287 may also move away from one another in anabsence of reduced pressure to form an open position, as shown in FIG.5. In the open position, a space 289 exists between the first wall 285and the second wall 287 to allow the liquid 250 in the reservoir 224 toflow out of the reservoir 224 and into the second delivery conduit 231,as indicated by arrows 291. The second delivery conduit 231 may thendeliver the liquid 250 to a tissue site.

When the second valve 227 is in the open position, the liquid 250 maypass through a second end 292 of the foam member 255. In addition, themovement of the first wall 285 away from the second wall 287 in theabsence of reduced pressure may be assisted by the second end 292 of thefoam member 255. The second end 292 of the foam member 255 may be anenlarged end portion 293. The second end 292 of the foam member 255 maybias the first wall 285 away from the second wall 287. Thus, the secondend 292 of the foam member 255 assists in opening the second valve 227in the absence of reduced pressure at the second valve 227.

The apparatus 206 may also include a set of restriction strips, e.g.,294, 295, and 296. The set of restriction strips may include one or morerestriction strips. The set of restriction strips 294, 295, and 296 aredisposed over at least a portion of the reservoir 224. The set ofrestriction strips 294, 295, and 296 are operable to restrict expansionof the reservoir 224 to contain a maximum amount of the liquid 250. Eachof the set of restriction strips 294, 295, and 296 is removable from thereservoir 224 to increase the maximum amount of the liquid 250 that maybe held by the reservoir 224. To provide one non-limiting example, thereservoir 224 may be able to hold 10 milliliters of the liquid 250 whenrestriction strips 294, 295, and 296 are applied to the reservoir 224.Restriction strip 294 may be removed from the reservoir 224 to increasethe maximum amount of the liquid 250 that is holdable by the reservoir224 to 15 milliliters. Restriction strip 295 may be removed from thereservoir 224 to increase the maximum amount of the liquid 250 that isholdable by the reservoir 224 to 20 milliliters. In addition, all of therestriction strips 294, 295, and 296 may be removed from the reservoir224, in which case the reservoir 224 may be allowed to expand to amaximum capacity. While specific illustrative examples are provided,i.e., 10 milliliters, 15 milliliters, and 20 milliliters, it should beunderstood that any volume may be used for the reservoir 224 and thevolume provided with restriction strips 294, 295, 296.

In another embodiment, the apparatus 206 may include a column (notshown) that is slidably coupled to the reservoir 224. The column may beslidable into a plurality of positions, and may be slidable along thelength, width, or thickness of the reservoir 224. The position of thecolumn determines a maximum amount of the liquid 250 that may be held bythe reservoir 224. In one example of this embodiment, the reservoir 224may be a syringe that has a valve on each end. The syringe may alsoinclude an internal slidable column.

In operation according to one embodiment, reduced pressure may beapplied to the apparatus 206 to change the positions of the first valve218 and the second valve 227, and thereby manage the flow of the liquid250 to a tissue site. In FIG. 4, reduced pressure is transmitted from areduced-pressure source, such as the reduced-pressure source 115 in FIG.1, to the first valve 218 and the second valve 227 via thereduced-pressure conduit 221. The reduced pressure may be transmittedfrom the reduced-pressure source 115 via a tissue site. As shown in FIG.4, the first valve 218 has an open position in the presence of reducedpressure at the first valve 218, and the second valve 227 has a closedposition in the presence of reduced pressure at the second valve 227.Thus, in FIG. 4, the reservoir 224 receives the liquid 250 from a liquidsource, and the second valve 227 obstructs the liquid 250 from flowingout of the reservoir 224. The set of restriction strips 294, 295, and296 may restrain the expansion of the reservoir 224 such that thereservoir 224 is able to hold a predetermined maximum amount of theliquid 250. In one example, this predetermined maximum amount may be aprescribed dosage.

In FIG. 5, little or no reduced pressure is transferred from areduced-pressure source to the first valve 218 and the second valve 227via the reduced-pressure conduit 221. As result, as shown in FIG. 5, thefirst valve 218 has a closed position to obstruct the flow of the liquid250 into the reservoir 224, and the second valve 227 has an openposition to allow the liquid 250 to flow from the reservoir 224 to atissue site. The valves 218 and 227 could be structured to open andclose opposite to that described.

Referring now primarily to FIGS. 6A and 6B, a second valve 627, whichmay be used as the second valve 227 in FIG. 2, is shown according to anillustrative embodiment. In FIG. 6A, the second valve 627 is shown in anopen position. In FIG. 6B, the second valve 627 is shown in a closedposition. The second valve 627 includes spacers 697 and 698. In anabsence of reduced pressure at the second valve 627, the spacers 697 and698 bias the first wall 685 away from the second wall 687 to form thespace 689. The spacers 697 and 698 may be composed of any elasticresilient material that is either formed with apertures or is liquidpermeable.

Referring now primarily to FIG. 7, a schematic graph 700 illustratingthe level of reduced pressure over time in an apparatus, such asapparatus 106 in FIG. 1 or apparatus 206 in FIG. 2, for managing liquidflow associated with a tissue site is depicted in accordance with anillustrative embodiment. During time period 704, reduced pressure isapplied to the apparatus for managing liquid flow. The reduced pressuremay be supplied by a tissue site, which, in turn, receives reducedpressure from a separate reduced-pressure device or source, e.g., thereduced-pressure source 115 in FIG. 1, which may include a controller.Thus, in this example, the separate reduced-pressure device is turned onduring time period 704.

During time period 704, the reduced pressure is transferred to a firstvalve and a second valve, such as a first valve and a second valvedescribed in any of the illustrative embodiments. During time period704, the first valve is in an open position and the second valve is in aclosed position such that a reservoir, as described in any of theillustrative embodiments, fills with a liquid from a liquid source up toa predetermined or maximum volume. The liquid, however, is obstructedfrom exiting the reservoir and flowing to a tissue site during the timeperiod 704.

During the time period 705, the separate reduced-pressure source thatsupplies reduced pressure to the tissue site may be turned off, or maysupply a relatively lesser amount of reduced pressure than during thetime period 704. During the time period 705, the absence of reducedpressure at the first valve and the second valve causes the first valveto have a closed position and the second valve to have an open position.Thus, during the time period 705, the volume of liquid in the reservoiris allowed to exit the reservoir and flow to a tissue site. In onenon-limiting example, the reduced pressure may be oscillated between thereduced pressure in the time period 704 and the reduced pressure in thetime period 705 so that the flow of liquid to a tissue site may bemanaged in measured doses. In this example, the reduced pressuresupplied by the separate reduced-pressure source to the tissue site maybe turned off and on in predetermined time internals, such as the timeperiod 704 and the time period 705.

Although the present invention and its advantages have been disclosed inthe context of certain illustrative, non-limiting embodiments, it shouldbe understood that various changes, substitutions, permutations, andalterations can be made without departing from the scope of theinvention as defined by the appended claims. It will be appreciated thatany feature that is described in a connection to any one embodiment mayalso be applicable to any other embodiment.

We claim:
 1. A method for managing liquid flow associated with a tissuesite, the method comprising: providing a valve arrangement with a firstvalve, a second valve, and a reservoir; fluidly coupling the first valveto a liquid source; fluidly coupling the second valve to the tissuesite; causing the first valve to change to one of an open position or aclosed position by transferring reduced pressure to the first valve; andcausing the second valve to change to the other of the open position orthe closed position by transferring reduced pressure to the secondvalve.
 2. The method of claim 1, wherein causing the first valve tochange to one of the open position or the closed position includeschanging a position of the first valve from the closed position to theopen position in the presence of reduced pressure.
 3. The method ofclaim 1, wherein causing the first valve to change to one of the openposition or the closed position includes changing a position of thefirst valve from the open position to the closed position in an absenceof reduced pressure.
 4. The method of claim 1, further comprising:receiving liquid at a reservoir when the first valve is in the openposition.
 5. The method of claim 1, further comprising: receiving liquidat the tissue site when the second valve is in the open position.
 6. Themethod of claim 1, the first valve and the second valve being configuredto receive reduced pressure through a reduced-pressure conduit.
 7. Themethod of claim 6, wherein the reduced-pressure conduit is configured totransfer reduced pressure from the tissue site to the first valve andthe second valve.
 8. A method for managing liquid flow associated with atissue site, the method comprising: providing a valve arrangement with afirst valve, a second valve, and a reservoir; fluidly coupling the firstvalve to a liquid source; fluidly coupling the second valve to thetissue site; changing a position of the first valve to one of an openposition or a closed position based on a presence of reduced pressure atthe first valve; changing a position of the second valve to the other ofthe open position or the closed position based on a presence of reducedpressure at the second valve; and receiving liquid at the tissue site,through the second valve, when the second valve is in the open position.